GlobeNewswire Inc | Mar 19, 2021 01:00PM EDT

March 19, 2021

WILLIAMSVILLE, N.Y., March 19, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today congratulated Xavier Becerra as the new Secretary of the U.S. Department of Health and Human Services (HHS). The Company believes that Becerras confirmation may reignite the U.S. Food and Drug Administrations (FDA) ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agencys plan to render all cigarettes minimally or non-addictive.

We congratulate Secretary Becerra on his well-deserved confirmation to this critically important role, said James A. Mish, chief executive officer of 22nd Century. Among his many accomplishments, Secretary Becerra has demonstrated leadership when it comes to one of the most important public health crises of our time: tackling cigarette addiction. 22nd Century urges the HHS to continue this important work by implementing a nicotine cap for all combustible cigarettes to a minimally or non-addictive level. We look forward to joining Secretary Becerra, the HHS, and the FDA on tackling the pressing public health tragedy caused by addictive cigarettes that is costing millions of Americans lives and billions of dollars each year.

Secretary Becerra is a long-time proponent of a reduced nicotine cap for cigarettes and tougher regulation for the tobacco industry. While serving as the attorney general of California in 2018, Becerra and five other attorney generals wrote a letter in response to the FDAs Advance Notice of Proposed Rulemaking (ANPRM), strongly supporting a tobacco product standard for nicotine level of combusted cigarettes. In the letter, Becerra, and others highlighted their extensive interest in and engagement with tobacco policy, regulation, and enforcement and their substantial experience and expertise regulating the tobacco industry. They also applaud[ed] FDA for considering a nicotine product standard and stated that [t]he nicotine standard should apply to all combusted products. The appointment of Becerra as Secretary of HHS is yet another signal from the Biden Administration that points to a favorable political climate for the renewal of the reduced nicotine mandate and a continued outsized focus on improving public health. Public health researchers project that the enactment of a nicotine cap will help more than five million people to quit smoking within the first year of implementation and will save more than eight million American lives by the end of the century.

Engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN is the only combustible product that complies with the FDAs proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence; smoke fewer cigarettes per day; increase their number of smoke-free days; and double their quit attempts all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company believes that it is in the final stages of the FDAs application process to obtain a Modified Risk Tobacco Product (MRTP) designation for VLN. The designation will allow 22nd Century to communicate key features of VLN King and VLN Menthol King, including, a headline claim of 95% less nicotine. Although it contains just 0.5 milligrams of nicotine per gram of tobacco, VLN tastes, smells, and smokes like a conventional cigarette. This disruptive product is an alternative to addictive, traditional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN brand and tobacco franchise. The Company remains committed to licensing its technology to every cigarette manufacturer so that Big Tobacco can join in the effort to reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

About 22nd Century Group,Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Centurys primary mission in tobacco is to reduce the harm caused by smoking through the Companys proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes. The Companys primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more atxxiicentury.com, on Twitter@_xxiicentury, and onLinkedIn.

Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as anticipate, believe, consider, continue, could, estimate, expect, explore, foresee, goal, guidance, intend, likely, may, plan, potential, predict, preliminary, probable, project, promising, seek, should, will, would, and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in Risk Factors in the Companys Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:Mei KuoDirector, Communications & Investor Relations22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com